You might be surprised to learn that it is legal to patent a human gene. I was. It is estimated that approximately 20% of the roughly 24,000 genes in the human DNA sequence have been patented. This has touched off a bioethics issue and spawned a lawsuit designed to test whether a natural substance such as a gene can be patented for protected private use. You can read a CNN article on it here.
The American Civil Liberties Union has brought suit on behalf of breast cancer survivor Lisbeth Ceriani against the Patent and Trade Office and Myriad Genetics over patents on two genes: BRCA1 and BRCA2. These genes are known to increase the risk of breast and ovarian cancers. Now Ceriani is contemplating whether to have her ovaries removed, and intends to if she has either of the telltale genes. But since the PTO granted Myriad a patent on these genes, Ceriani (and others) cannot get a diagnosis on whether she has them without the permission of the company--a privilege for which Myriad charges $3,000 for the use of its "intellectual property."
The ACLU contends that, "patenting a gene is as wrong as patenting a basic element like gold or a basic law of nature like gravity. When it patents a gene, the U.S. Patent and trade office (PTO) is really patenting knowledge, which violates freedom of scientific inquiry." According to the ACLU Journal Civil Liberties, "Patents were designed to protect human inventions, and you can't invent a gene."
As an outgrowth of this practice, other researchers are barred from looking into someone's patented gene. According to Wired, Myriad Genetics has "issued a cease-and-desist order to Yale University scientists researching the genes." The ACLU suit thus asks the federal judiciary to rule against the patenting practice on grounds of infringing on freedom of speech and scientific inquiry as well as on establishing favored and protected monopolies on natural substances. In short, the whole concept of patenting a human gene will come under argument and be subject to legal review.
The decision, when it comes, will have far-reaching effects. Currently, about 63% of patents on genes are held by companies and 37% by universities. Is it right for anyone to own a patent on a naturally occurring substance or component of the human body? Is it right to grant such an entity sole discretion on whether a person can get a test to determine if the substance may give them a disease or how much they must pay for the rights to have that test done? Is it legitimate to allow them to bar medical researchers from looking into the gene, natural substance or body component and thus to curtail any potentially life-saving medical investigation into it for the life of the patent? How many lives might such theories ultimately cost?
1 comment:
Another example of how patent laws affect science and society. John Cade, an Austrailian psychiatrist, discovered in the early 1950's that lithium carbonate reduced the mania of bi-polar patients. However, lithium carbonate turns out to be a very simple molecule (lithium plus carbon plus oxygen, only five atoms large)and easily found in nature - thus not patent-able. Because of this fact, it took until 1970 before any American pharmaceutical company found it worthwhile to bring to market. Big pharma likes to boast how their private market research dollars bring medications to the public. In some cases, it also delays bringing medications to the public.
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